CERTIFICATIONS & COMPLIANCE
Compliance is a purchasing gate, not a marketing badge.
Buyers in the EU, North America and regulated food or pharma environments cannot issue a purchase order until conformity is documented. This page states which directives and standards each machine architecture is built against, what documentation ships with the machine, and where the boundaries of our declaration end.
ILLUSTRATIVE — every standard, notified body and certificate number below must be replaced with verified documents before publication.
WHAT SHIPS WITH THE MACHINE
Conformity documentation set
A machine without its documentation set cannot be commissioned in most regulated plants. These items are prepared during build and handed over at FAT.
01
Declaration of Conformity
EC Declaration of Conformity listing applied directives, harmonised standards and the authorised representative. Issued per serial number.
02
Technical File
Risk assessment, general arrangement drawings, electrical schematics, component certificates and validation records. Retained and available to authorities on request.
03
Operating & Maintenance Manual
Installation, safe operation, changeover, cleaning, lubrication and maintenance intervals. Supplied in the destination market language.
04
Material Contact Declarations
Food-contact conformity statements for product-contact components, referencing the applicable regional regulation.
05
Electrical Test Records
Continuity, insulation resistance and functional safety verification records from final assembly and FAT.
06
Component Certificate Index
Certificates for safety-relevant bought-in components: safety relays, light curtains, motors, drives and pneumatic safety elements.
STANDARDS BY MARKET
Which framework applies where
Requirements differ by destination and by product category. The table states the framework each machine is built against — not a claim that every model carries every certificate.
| Destination / context | Primary framework | Typical scope | Status |
|---|---|---|---|
| European Union / EEA | Machinery Regulation, EMC and Low Voltage directives | CE marking, Declaration of Conformity, technical file, harmonised standards | Standard on all models |
| United States / Canada | NFPA 79 electrical build, UL/CSA listed components | Panel build to NFPA 79, listed components, field evaluation where required | Optional build specification |
| Hygienic food processing | EHEDG design principles, 3-A where applicable | Cleanable surfaces, drainage, material selection, documented cleaning access | Model dependent — confirm per application |
| Explosive dust atmospheres | ATEX / IECEx zone classification | Zone-rated components, earthing, dust-tight enclosures, ignition risk assessment | Engineered to order |
| Pharmaceutical | GAMP-aligned documentation, IQ/OQ support | Validation documentation pack, calibration certificates, audit trail on controls | Engineered to order |
| Quality management | ISO 9001 quality management system | Documented procedures, traceability, corrective action, internal audit | Organisation level |
HOW TO VERIFY
Do not take a logo wall as evidence
Certificate logos on a website prove nothing. These are the checks a procurement or quality team should run on any supplier, including us.
CHECK 01
Ask for the certificate itself
A PDF with issuing body, certificate number, scope statement, issue date and expiry date. A logo image is not a certificate.
CHECK 02
Confirm the scope covers your model
Certificates are issued for defined scopes. A certificate covering one machine family does not automatically cover another.
CHECK 03
Verify with the issuing body
Most notified bodies and registrars publish a searchable register. Certificate numbers can be checked independently in minutes.
CHECK 04
Separate component from machine
A machine containing UL-listed components is not itself a listed machine. Ask which applies.
BOUNDARIES
What our declaration does not cover
Stating limits is part of a credible conformity claim.
- ×Packaging material performance — film, laminate and pouch behaviour is the responsibility of the material supplier
- ×Product-specific regulatory approval — the packaged product’s own registration or approval is the buyer’s responsibility
- ×Site-level compliance — factory electrical infrastructure, guarding interfaces with adjacent equipment, and local installation permits
- ×Modifications after delivery — any change to the machine invalidates the declaration unless carried out under written agreement
- ×Third-party equipment integrated by others into the same line
COMMON QUESTIONS
Questions buyers ask before a technical discussion
For most packaging machinery, conformity is self-declared by the manufacturer on the basis of a technical file and applied harmonised standards. A notified body is only involved for specific higher-risk machine categories. Ask any supplier which route applies and request the technical file summary.
Yes, but it is a build specification decided before manufacturing, not a certificate added afterwards. Electrical panel construction, component selection and labelling differ. Specify the destination market in the RFQ.
It states that documented procedures exist and are audited. It says nothing about the performance of a specific machine. Use it as a baseline filter, not as evidence of technical capability.
Each machine carries its own conformity documentation, and the party who assembles them into one line assumes responsibility for the line-level assessment and declaration. Agree in writing who takes that role before the purchase order.
START WITH THE APPLICATION
Need the documentation pack for a specific model and market?
Tell us the destination country, the product category and the plant environment. We will state exactly which framework applies and what documentation ships with the machine.